BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964931 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01406
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 10, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS FRACTURED. IT WAS NOTED THAT THE OUTER TUBING OVERLAY WAS MELTED AND WAS BREACHED CUT. THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND OVERLAY TUBING HAD ENVIRONMENTAL STRESS CRACKING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED DUE TO HIGH DEFIBRILLATION COIL IMPEDANCE. A LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66844 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Hospitalization| R